Last reviewed · How we verify

NCT04802343

A Trial to Learn How BAY1817080 Moves Into, Through and Out of the Body and How Safe it is in Healthy Chinese Men

Completed Phase 1 Last updated 19 October 2022
What this trial tests

Phase 1 trial testing BAY1817080 in Healthy Volunteers in 39 participants. Completed in 29 October 2021.

Timeline
2 April 2021
Primary endpoint
19 July 2021
29 October 2021

Quick facts

Lead sponsorBayer
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingquadruple
Primary purposeother
Enrollment39
Start date2 April 2021
Primary completion19 July 2021
Estimated completion29 October 2021
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Bayer — full company profile →

Who can join

Adults 18 to 45, male only, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Researchers are looking for a better way to treat chronic cough. Before patients with medical conditions can join clinical trials, researchers do trials in healthy participants first to understand how the body acts on the new treatment and learn how safe it is. In this trial, the researchers will study how much of the trial drug, BAY1817080, gets into the blood in a small number of participants. The trial will include about 39 healthy Chinese male who are aged 18 to 45. For this trial participants will be divided in 3 groups. Groups 1 and 2 will take either dose 1 or dose 2 of BAY1817080 or placebo 1 time. Participants of groups 3 will take dose 3 of BAY1817080 or placebo one time at the first day and continue to take dose 3 of BAY1817080 twice a day from day 7 to day 16 of the trial. On day 17 they will take only one dose 3 of BAY1817080. All participants will take BAY1817080 or a placebo as a tablet by mouth. For this trial, the participants in Groups 1 and 2 will stay at the trial site for up to 10 days. The participants in Group 3 will stay at the trial site for up to 26 days. The trial will last up to 4 weeks for the participants in Groups 1 and 2, and 6 weeks for the participants in Group 3. During the trial, the doctors will take blood and urine samples and check the participants blood pressure, pulse rate and electrocardiogram (ECG). The participants will answer questions about how they are feeling to check their general wellbeing.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. P2X3 Receptor Antagonist Eliapixant in Phase I Clinical Trials: Safety and Inter-ethnic Comparison of Pharmacokinetics in Healthy Chinese and Japanese Participants.
    Li X, Haranaka M, Li H, Liu P, et al · · 2024 · PMID 38907175 · DOI 10.1007/s40262-024-01387-y

Verify or expand the search:

Other trials of BAY1817080

Trials testing the same drug.

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

Other Bayer trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04802343.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing